Medical Writer - Hybrid

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 420,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Generous paid time off

Job summary

Placements24 in Nelspruit, Mpumalanga, ZA, seeks a Medical Writer to join a hybrid team focused on regulatory submissions, CSRs, and medical communications. You will work cross-functionally with clinical development, regulatory, and medical affairs to deliver scientifically sound documents.

The ideal candidate has a life sciences master or PhD, at least 3 years of experience, and strong writing, editing, and data interpretation skills.

Qualifications

• Master's or PhD in life sciences or related field.
• At least 3 years as a Medical Writer in pharma/biotech/CRO.
• Experience writing CSRs and regulatory submissions.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Excellent writing, editing, and proofreading skills.
• Ability to interpret complex scientific data.

Responsibilities

• Write, edit, and review CSRs, protocols, investigator brochures, safety narratives, and submission dossiers.
• Ensure materials are scientifically accurate and meet guidelines and timelines.
• Collaborate with SMEs to gather information and ensure scientific integrity.
• Manage document development from planning to drafting and revising.
• Contribute to standardized templates and style guides for medical writing.
• Review and interpret complex data sets to create clear summaries.
• Stay current with literature, therapeutic areas, and regulatory requirements.
• Participate in team meetings and strategic medical communications.

Skills

Medical writing

Scientific writing

Editing

Communication

Education

Master's degree in life sciences

PhD in life sciences

Tools

Microsoft Word

Document management systems

Job description

About the Role

Our client, a progressive pharmaceutical company focused on innovative therapies, is seeking a skilled Medical Writer to join their collaborative team in **Nelspruit, Mpumalanga, ZA**. This hybrid role offers the opportunity to craft clear, accurate, and scientifically sound documents that support regulatory submissions, clinical trial reporting, and medical communications. You will work closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure the highest quality of written scientific output. This position is ideal for a detail-oriented writer with a strong scientific background looking to make a significant contribution to drug development and medical knowledge dissemination.

Key Responsibilities

• Write, edit, and review a variety of complex clinical and regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, safety narratives, and submission dossiers.
• Ensure all written materials are scientifically accurate, adhere to relevant guidelines (e.g., ICH, regulatory agency requirements), and meet project timelines.
• Collaborate with subject matter experts (SMEs) to gather necessary information and ensure the scientific integrity of documents.
• Manage document development processes, including planning, outlining, drafting, and revising content.
• Contribute to the development and implementation of standardized templates and style guides for medical writing.
• Review and interpret complex data sets to create clear and concise summaries and narratives.
• Stay current with scientific literature, therapeutic area advancements, and regulatory requirements.
• Participate in team meetings and contribute to strategic discussions related to medical communications.

Requirements

• Master's degree or Ph.D. in a life science, medical, or related field.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated expertise in writing clinical study reports (CSRs) and other regulatory submission documents.
• Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical documentation.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to understand and interpret complex scientific and medical data.
• Proficiency in Microsoft Word, and familiarity with document management systems.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively in a hybrid team setting in **Nelspruit, Mpumalanga, ZA**.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, a retirement fund, and generous paid time off. This hybrid role provides a flexible work arrangement, allowing for an effective work-life balance. You will have the opportunity to work on diverse and challenging projects within the pharmaceutical industry. Professional development and continuous learning opportunities will be provided. Join a dynamic and innovative team dedicated to advancing healthcare through clear and accurate scientific communication from our offices in **Nelspruit, Mpumalanga, ZA**.